Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness

NCT ID: NCT06292052

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-04-01

Brief Summary

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The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neoadjuvant immunochemotherapy NSCLC group

NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery.

Immunotherapy

Intervention Type DRUG

Received neoadjuvant chemotherapy plus immunotherapy

Interventions

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Immunotherapy

Received neoadjuvant chemotherapy plus immunotherapy

Intervention Type DRUG

Other Intervention Names

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Chemotherapy

Eligibility Criteria

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Inclusion Criteria

* pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy
* clinically staged as T1-4N0-2M0
* having undergo neoadjuvant chemoimmunotherapy
* the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors
* having undergo surgery with lymph nodes (LNs) dissection
* having postoperative pathology reports with evaluation of primary tumor and LNs response
* having accessible pretreatment and preoperative radiology examinations imaging or reports

Exclusion Criteria

* using PD-1/L1 inhibitors in the phase of clinical trials
* the agents of neoadjuvant therapy including angiogenesis inhibitors
* having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangmen Central Hospital

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Hao Long

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Rahim MK, Okholm TLH, Jones KB, McCarthy EE, Liu CC, Yee JL, Tamaki SJ, Marquez DM, Tenvooren I, Wai K, Cheung A, Davidson BR, Johri V, Samad B, O'Gorman WE, Krummel MF, van Zante A, Combes AJ, Angelo M, Fong L, Algazi AP, Ha P, Spitzer MH. Dynamic CD8+ T cell responses to cancer immunotherapy in human regional lymph nodes are disrupted in metastatic lymph nodes. Cell. 2023 Mar 16;186(6):1127-1143.e18. doi: 10.1016/j.cell.2023.02.021.

Reference Type RESULT
PMID: 36931243 (View on PubMed)

Prokhnevska N, Cardenas MA, Valanparambil RM, Sobierajska E, Barwick BG, Jansen C, Reyes Moon A, Gregorova P, delBalzo L, Greenwald R, Bilen MA, Alemozaffar M, Joshi S, Cimmino C, Larsen C, Master V, Sanda M, Kissick H. CD8+ T cell activation in cancer comprises an initial activation phase in lymph nodes followed by effector differentiation within the tumor. Immunity. 2023 Jan 10;56(1):107-124.e5. doi: 10.1016/j.immuni.2022.12.002. Epub 2022 Dec 28.

Reference Type RESULT
PMID: 36580918 (View on PubMed)

Other Identifiers

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NSCLC-TDLN-001

Identifier Type: -

Identifier Source: org_study_id

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